Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks
pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Castle Rock, Colorado, United States
Unnamed facility
Jacksonville, Florida, United States
The primary efficacy parameter was the percent change in LDL-C from baseline to endpoint.
Time frame: 6 weeks
The absolute change in LDL-C from baseline to endpoint.
Time frame: 6 weeks
The absolute change and % change of total cholesterol from baseline to endpoint
Time frame: 6 Weeks
The absolute change and % change of triglycerides from baseline to endpoint
Time frame: 6 Weeks
The absolute change and % change of HDL-C from baseline to endpoint
Time frame: 6 Weeks
The absolute change and % change of c-reactive protein from baseline to endpoint
Time frame: 6 weeks
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Unnamed facility
Pembroke Pines, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Cincinnati, Ohio, United States
...and 5 more locations